Suture passers adapted for use in constrained regions

ABSTRACT

Described herein suture passer apparatus (devices and systems) that may be used to suture tissue within a narrow, confined space. In particular, described herein are suture passers having an elongate body and a bent lower jaw member that houses a tissue penetrator that is adapted to extend laterally through the bend region, and then be laterally deflected from the lower jaw member to a second jaw (e.g. bendable or pivoting) upper member.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of U.S. patent applicationSer. No. 14/681,528, filed Apr. 8, 2015, titled “SUTURE PASSERS ADAPTEDFOR USE IN CONSTRAINED REGIONS,” which claims the benefit of U.S.Provisional Patent Application No. 61/976,742, filed Apr. 8, 2014,titled “SUTURE PASSERS ADAPTED FOR USE IN CONSTRAINED REGIONS”. Thisapplication is herein incorporated by reference in its entirety.

This patent application may be related to one or more of U.S. patentapplication Ser. No. 14/265,848, filed on Apr. 30, 2014, titled “SUTUREPASSER WITH RADIUSED UPPER JAW,” now U.S. Pat. No. 9,011,454; U.S.patent application Ser. No. 14/292,695, filed on May 30, 2014, titled“SUTURE METHODS FOR FORMING LOCKING LOOPS STITCHES,” Publication No.US-2014-0276987-A1; U.S. patent application Ser. No. 13/247,892, filedon Sep. 28, 2011, titled “MENISCUS REPAIR,” Publication No.US-2012-0283750-A1; U.S. patent application Ser. No. 13/323,391, filedon Dec. 12, 2011, titled “SUTURE PASSER DEVICES AND METHODS,”Publication No. US-2012-0283753-A1; U.S. patent application Ser. No.13/893,154, filed on May 13, 2013, titled “SUTURE PASSER DEVICES ANDMETHODS,” Publication No. US-2013-0331865-A1; U.S. patent applicationSer. No. 13/759,006, filed on Feb. 4, 2013, titled “SUTURE PASSERS,”Publication No. US-2014-0222034-A1; U.S. patent application Ser. No.14/546,942, filed on Nov. 18, 2014, titled “SUTURE PASSER AND METHOD FORHIP LABRUM REPAIR,” Publication No. US-2015-0073442-A1; U.S. patentapplication Ser. No. 13/844,252, filed on Mar. 15, 2013, titled “SUTUREPASSERS AND METHODS OF PASSING SUTURE,” Publication No. Publication No.US-2014-0276981-A1; and U.S. patent application Ser. No. 14/572,485,filed on Dec. 16, 2014, titled “AUTOMATICALLY RELOADING SUTURE PASSERDEVICES AND METHODS”.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

Suture passer apparatus, including devices and systems, as well asmethods of making and using such apparatus are described herein. Inparticular, suture passer apparatus adapted for use in narrow, confined,and/or difficult to access regions of a body, such as a knee joint.

BACKGROUND

Suturing of tissue during surgical procedures is time consuming and canbe particularly challenging in difficult to access body regions andregions that have limited clearance, such as regions partiallysurrounded or covered by bone. For many surgical procedures, it isnecessary to make a large opening in the human body to expose the arearequiring surgical repair. However, in many cases, accessing the tissuein this manner is undesirable, increasing recovery time, and exposingthe patient to greater risk of infection.

Suturing instruments (“suture passers” or “suturing devices”) have beendeveloped to assist in accessing and treating internal body regions, andto generally assist a physician in repairing tissue. Although many suchdevices are available for endoscopic and/or percutaneous use, thesedevices suffer from a variety of problems, including limited ability tonavigate and be operated within the tight confines of the body, risk ofinjury to adjacent structures, problems controlling the position and/orcondition of the tissue before, during, and after passing the suture,and difficulties loading the suture into the device, particularly forthreading multiple suture loops.

For example, some surgical instruments used in endoscopic procedures arelimited by the manner in which they access the areas of the human bodyin need of repair. In particular, the instruments may not be able toaccess tissue or organs located deep within the body or that are in someway obstructed. In addition, many of the instruments are limited by theway they grasp tissue, apply a suture, or recapture the needle andsuture. Furthermore, many of the instruments are complicated andexpensive to use due to the numerous parts and/or subassemblies requiredto make them function properly. Suturing remains a delicate andtime-consuming aspect of most surgeries, including those performedendoscopically.

Some variations of suture passers, such as those described in U.S. Pat.No. 7,377,926 to Taylor, have opposing jaws that open and close overtissue. One, or in some variations, both, jaws open, scissor-like, sothat tissue may be inserted between the open jaws. Unfortunately, suchdevices cannot be adequately positioned for use in hard to navigate bodyregions such as the joints of the body, including the knee (e.g.,meniscus) and the shoulder because there is not room within the confinesof the body (e.g., joint region) to open the scissoring jaws.

The knee joint is one example of a tissue region that is notoriouslydifficult to access. For example, the meniscus is a C-shaped piece offibrocartilage which is located at the peripheral aspect of the joint(e.g., the knee) between the condyles of the femur and the tibia on thelateral and medial sides of the knee. The central two-thirds of themeniscus has a limited blood supply while the peripheral one thirdtypically has an excellent blood supply. Acute traumatic events commonlycause meniscus tears in younger patients while degenerative tears aremore common in older patients as the menisci become increasingly brittlewith age. Typically, when the meniscus is damaged, a torn piece ofmeniscus may move in an abnormal fashion inside the joint, which maylead to pain and loss of function of the joint. Early arthritis can alsooccur due to these tears as abnormal mechanical movement of tornmeniscal tissue and the loss of the shock absorbing properties of themeniscus lead to destruction of the surrounding articular cartilage.Occasionally, it is possible to repair a torn meniscus. While this maybe done arthroscopically, surgical repair using a suture has provendifficult to perform because of the hard-to-reach nature of the regionand the difficulty in placing sutures in a way that compresses andsecures the torn surfaces.

Arthroscopy typically involves inserting a fiberoptic telescope that isabout the size of a pencil into the joint through an incision that isapproximately ⅛ inch long. Fluid may then be inserted into the joint todistend the joint and to allow for visualization of the structureswithin that joint. Then, using miniature instruments which may be assmall as 1/10 of an inch, the structures are examined and the surgery isperformed.

The meniscus of the knee is just one example of a tissue that isdifficult to access so that appropriate suturing may be performed.

Thus, there is a need for methods and apparatuses (e.g., devices andsystems) for suturing tissue, particularly tissue in difficult to accessregions of the body including the joints (shoulder, knee, etc.). Inparticularly, it has proven useful to provide a device that may simplyand reliably reach and pass sutures within otherwise inaccessible tissueregions. Such devices should be extremely low profile, and may beadapted or otherwise configured to fit in the tight spaces of thejoints. Finally, would be useful to provide suturing apparatuses thatallow selective and specific penetration of the tissue by both thetissue penetrator (needle element) and a jaw so that complex (includingright-angled) suturing patterns may be achieved.

There is also a need for methods and apparatuses for suturing tissue. Inparticular, it has proven useful to provide a device that may simply andreliably reach and pass sutures within otherwise inaccessible tissueregions. Further, there is a need for suture passers that can beautomatically loaded (or preloaded) pass multiple lengths (e.g., bights)of suture though the tissue without requiring that they be manuallyreloaded, either within the tissue or by withdrawing them from thetissue.

Although limited space in tight joints is frequently a limiting factorin soft tissue repair within joints, described herein are apparatusconfigured to facilitate suture passing in such tight joints. Theapparatus (e.g., devices and systems) described herein may pass suturesvertically through soft tissue, with a tissue penetrator (e.g., needle)that extends out of a lower jaw at or near a 90° angle. After passingthrough the tissue, the tissue penetrator contacts an upper jaw (or income variations, a condyle protective element), which deflects theneedle again, so that the needle extends in a serpentine path, eitherdeflected distally or deflected proximally.

SUMMARY OF THE DISCLOSURE

In general, described herein suture passer apparatus (devices andsystems) that may be used to suture tissue within a narrow, confinedspace.

For example, a suture passer may include an elongate body and a fixed orlaterally movable (e.g., extendable and retractable) lower jaw memberfrom which a tissue penetrator (needle) may extend. The tissuepenetrator may be held within the lower jaw member and may be extendeddistally from a side region of the lower jaw member and deflected fromthe side of the lower jaw through the tissue, particularly when thetissue is held between the lower jaw and an upper jaw. The lower jaw maybe bent or straight. In some variations the lower jaw may be hinged orbendable. The suture passer may also include an upper jaw that acts as ashield or deflector to deflect the needle (tissue penetrator) after itextends through the tissue from the lower jaw. The upper jaw may beadapted to extend from within the elongate body, rotate/pivot relativeto the elongate body, and/or may be fixed relative to the elongate body.The upper jaw may be extremely thin and sufficiently strong to deflectthe tissue penetrator. In some variations the upper jaw is pre-biased tocurve away from the elongate axis of the elongate body, e.g., to form av-shaped opening when extended.

The upper jaw may include a suture securing region near its distal endso that a suture passed by a tissue penetrator is held by the upper jawuntil the device is retracted from the tissue.

Some variations of suture passers and methods described herein includeonly a lower jaw that is fixed or bendable and/or slideable. The lowerjaw houses a tissue penetrator that may be extended laterally from aside-opening in the lower jaw. Although an upper jaw is not included, aseparate shield member may be positioned laterally from the targettissue to be sutures, and used to deflect the tissue penetrator fromnon-target tissue.

In variations including an upper arm (opposite from the arm housing thetissue penetrator) may also include a suture retainer on upper arm. Forexample, the upper arm may include a passage, opening, or loop throughwhich the tissue penetrator passes after being deflected against atissue deflection surface. When the tissue penetrator is retracted backthrough the tissue, the suture (which may be loaded into the tissuepenetrator and pushed through the tissue from the lower jaw with thetissue penetrator) may be retained. A loop or bight of tissue may bepassed and retained on the opposite side of the target tissue, e.g., inthe upper arm. In some variations the second (upper) jaw may include asuture retainer that includes a leaf spring or other clamping mechanismthat clamps the suture between two or more surfaces to hold it. In somevariations the upper jaw includes a region that is adapted to bepenetrated by the tissue penetrator (e.g., a mesh region, a region thatis made of a “soft” material such as silicone, etc.); when retractingthe needle back to the lower jaw, the suture will be retained by theupper jaw.

Also described herein are suture passer apparatus having lower jaws(housing the tissue penetrator) that have very narrow (e.g., less than20 mm, less than 10 mm, less than 5 mm) widths. When operating thesedevices, they may be turned sideways to position within a confinedspace, and rotated over to operate. The distal end of the suture passer,and in particular a suture passer having a very narrow lower jaw, may bebent or curved to one side, enhancing positioning within the narrowconfines of the tissue.

For example, a suture passer apparatus adapted for insertion into a kneejoint as described herein may include: an elongate body having aproximal end connected to a proximal handle and a distal end region,wherein the elongate body extends in a long axis; a lower jaw memberextending from the distal end region of the elongate body, the lower jawincluding a bend relative to the long axis of the elongate body at aproximal end of the lower jaw, wherein a bottom surface of the lower jawfrom the bend to the distal end of the lower jaw is flat and extends ina straight line to a rounded distal end region; an upper jaw memberextending from a distal end region of the elongate body and bendablerelative to the elongate body, wherein the upper jaw member bends awayfrom the long axis of the elongate body in a same direction as the bendin the lower jaw member; and a tissue penetrator housed within the lowerjaw member configured to slide distally in the lower jaw member beyondthe bend and extend laterally out of the lower jaw member to transfer aloop of suture from the lower jaw member through the upper jaw member.

In general, the bend in the lower jaw member may be engineeredspecifically to facilitate the insertion into the knee joint. Forexample, the bend may be any angle is between about 5 degrees and about40 degrees, relative to the long axis of the elongate body. The bend maybe located at any position along the lower jaw; e.g., it may be locatedat the proximal end of the lower jaw, or more distally from the proximaljaw. In some variations, the bend may be located opposite from the hingepoint of the upper jaw, or distal (e.g., slightly distal) to the hingelocation of the upper jaw, in variations in which the upper jaw ispivoting.

The tissue penetrator (which may be referred to as a needle herein) maybe generally thin, flat and elongate, and may be made of any appropriatematerial (e.g., Nitinol). In general, the tissue penetrator must beconfigured so that it can be bent multiple times during operation of thedevice. For example, the distal end region (e.g., 1 mm to 50 mm) of thetissue penetrator may be bent within the lower jaw member to navigatethe bend (e.g., the 5 degrees to 40 degree bend), and then deflected outof the lower jaw member to pass the suture from the lower jaw member tothe upper jaw member. Once the suture is passed through and engaged bythe upper jaw member, the tissue penetrator is retracted, pulling backwithin the lower jaw member.

For example, in some variations the lower jaw member comprises adeflection surface at or within the lower jaw member to deflect thetissue penetrator laterally out of the lower jaw member when the tissuepenetrator is slid distally.

As mentioned, in some variations, the lower jaw member is fixed relativeto the elongate body. In some variations, the bent lower jaw member isconfigured to pivot relative to the elongate body.

The upper jaw member may comprise a suture capture region adapted toreceive the loop of suture on the upper jaw when the tissue penetratoris retracted proximally after contacting the upper jaw member. Forexample, the upper jaw may include a suture capture comprising aclamping member. The lower jaw member may be thinner than a width of thelower jaw member over most of the proximal to distal length of the lowerjaw member.

For example, a suture passer apparatus adapted for insertion into a kneejoint may include: an elongate body having a proximal end connected to aproximal handle and a distal end region, wherein the elongate bodyextends in a long axis; a lower jaw member extending from the distal endregion of the elongate body, the lower jaw including a bend of between 5degrees and 40 degrees relative to the long axis of the elongate body ata proximal end of the lower jaw, wherein a bottom surface of the lowerjaw from the bend to the distal end of the lower jaw is flat and extendsin a straight line to a rounded distal end region; an upper jaw memberextending from a distal end region of the elongate body and pivotablerelative to the elongate body, wherein the upper jaw member pivots awayfrom the long axis of the elongate body in a same direction as the bendin the lower jaw member; and an elongate, thin and flat tissuepenetrator housed within the lower jaw member configured to slidedistally in the lower jaw member beyond the bend and extend a distal tipregion laterally out of the lower jaw member to transfer a loop ofsuture from the lower jaw member and through the upper jaw member.

Also described herein are methods of suturing tissue (e.g., using any ofthe devices described above). For example a method may include: loadinga loop of suture into a lower jaw member of a suture passer, wherein thesuture passer comprises an elongate body extending in a long axis, anupper jaw pivotally connected relative to the lower jaw, wherein thelower jaw member extends from a distal end region of the elongate body,the lower jaw including a bend relative to the long axis of the elongatebody at a proximal end of the lower jaw, wherein a bottom surface of thelower jaw from the bend to the distal end of the lower jaw is flat andextends in a straight line to a rounded distal end region; positioning atarget tissue in between the lower jaw and the upper jaw; closing thefirst jaw towards the second jaw to at least partially clamp the targettissue between the first jaw and the second jaw; and pushing a distalend region of a tissue penetrator from within the lower jaw to deflectlaterally out of the lower jaw through the target tissue and through theupper jaw, wherein the distal end region of the tissue penetrator iscarrying the loop of suture.

Positioning the target tissue in between the lower jaw and the upper jawmay include positioning a torn knee meniscus between the lower jaw andthe upper jaw. Positioning the target tissue in between the lower jawand the upper jaw may comprise sliding the lower jaw under an inferiorsurface of a knee meniscus and placing the upper jaw against thesuperior surface of the knee meniscus.

Loading the loop of suture into the lower jaw member of the suturepasser may include loading the loop of suture into the distal end of thetissue penetrator.

In any of the variations described herein, the proximal handle mayinclude a pair of controls, including a first control (e.g., lever,grip, handle, etc.) that actuates pivoting/bending of the upper jaw anda second control (e.g., lever, grip, handle, etc.) that actuatesextension/retraction of the tissue penetrator from the lower jaw to theupper jaw. Either or both controls may be spring operated, or otherwisebiased in one position (e.g., so that the upper jaw is biased in apivoted open position and/or the tissue penetrator is biased in aretracted, e.g., within the lower jaw, position). Closing the first jawtowards the second jaw may comprise squeezing a first control on aproximal handle of the suture passer. In addition or alternatively,pushing the distal end region of the tissue penetrator from within thelower jaw to deflect laterally out of the lower jaw through the targettissue and through the upper jaw may include squeezing a second controlon the proximal handle of the suture passer.

Pushing the distal end region of the tissue penetrator from within thelower jaw to deflect laterally out of the lower jaw through the targettissue and through the upper jaw may include retaining a proximalportion of the tissue penetrator within the lower jaw as the distal endregion is extended through the upper jaw.

Any of the methods described herein may also include stripping the loopof suture from the tissue penetrator and retaining the loop of suture onthe upper jaw after retracing the tissue penetrator back into the lowerjaw. For example, pushing the distal end region of the tissue penetratorfrom within the lower jaw to deflect laterally out of the lower jawthrough the target tissue and through the upper jaw may include pushingthe distal end region of the tissue penetrator against a clampingmechanism in the upper jaw as the distal end region is extended throughand out of the upper jaw.

Any of the methods described herein may also include releasing the loopof suture from the suture passer as the suture passer is removed fromthe tissue. For example, the loop may be released from the upper jaw byholding and/or pulling on the limbs of the suture loop while retractingthe suture passer out of the apparatus.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows an example of a suture passer device having an elongatebody with a proximal handle region and a distal lower jaw housing atissue penetrator that can exit from a lateral opening to extendperpendicularly (or nearly perpendicularly) from the lower jaw. FIGS.1B-1E show variations of different distal jaw regions that may be usedwith the elongate body and handle regions shown in FIG. 1A.

In FIG. 1B, a side view of the distal end region of the suture passerincludes a lower jaw that houses a tissue penetrator and is configuredto slide distally to proximally relative to (e.g., from) the distal endof the elongate body. An upper jaw comprising a pre-bent or curved stripof metal is adapted to deflect the tissue penetrator distally (though itmay be adapted to deflect it proximally).

FIG. 1C is similar to FIG. 1B, except the lower jaw member is fixedrelative to the elongate body and does not slide distally to proximally.As in FIG. 1B, the upper jaw may slide/extend distally and retractproximally from the elongate body and deflect the tissue penetrator.

FIG. 1D is similar to FIG. 1B, however the upper jaw is adapted toinclude a passage or deflector and/or tissue retainer at the distal endthat retains the bight of suture after is passed from the lower jaw tothe upper jaw.

FIG. 1E is similar to FIG. 1D except the lower jaw (as in FIG. 1C) isfixed relative to the elongate body.

FIGS. 2A-2E illustrates operation of a suture passer having a distal endwith a sliding lower jaw housing a tissue penetrator and an upper jawadapted as a thin deflector that extends and retracts into the elongatebody (including, in some variations, completely retracting into theelongate body). In FIG. 2A, the lower jaw with the tissue penetrator(which may be pre-loaded with suture) is extended and may be positionedagainst a target tissue. In FIG. 2B the upper jaw extends from theelongate body so that a target tissue (such as a meniscus of the knee)is positioned between the upper and lower jaws. In FIG. 2C the upper andlower jaws are completely extended. In FIG. 2D the tissue penetrator(needle) is extended laterally from within the lower jaw and extendedacross the tissue between the jaws. In FIG. 2E the tissue penetrator isdeflected a second time so that it is directed distally by the upperjaw. The tissue penetrator may carry a suture bight through the tissueand it may be retained on the opposite side of the tissue, either by asuture retainer region or by friction between the tissue and suture, orboth.

FIGS. 3A-3E illustrates a similar method of operating a suture passerhaving a fixed lower jaw (e.g., fixed and non-slideable relative to theelongate body).

FIGS. 4A-4F illustrate operation of a suture passer passing a pair ofsuture bights using a suture passer having a distal end similar to theone shown in FIGS. 1C and 3A-3E. The distal end of the suture passer isshown in profile, while the tissue is shown transparent (e.g., inpartial section) to illustrate the passage of the needle and suturetherethrough.

FIG. 5 illustrates one variation of an upper jaw having a hook at thedistal end. The hook may be used to capture and pull a bight of suturethat has been passed through the tissue.

FIGS. 6A-6C illustrate the operation of a suture passer having aclamping collar, configured as an outer collar or tube that can be usedto close the ‘jaws’ formed by an upper and lower jaw member of any ofthe distal end variations described, including those shown in FIGS.1B-1E. This may allow the device to clamp on the target tissue heldbetween the jaws, as illustrated.

FIGS. 7A-7E illustrate operation of a variation of the distal end of asuture passer device such as the one shown in FIG. 1D, in which thelower jaw is axially slideable distally to proximally, as is the upperjaw, and the upper jaw include a suture retainer region at the distalend. In general, the upper and lower jaws are independently movable (andslideable) as is the tissue penetrator.

FIGS. 8A-8E illustrates a side view of the operation of a variation ofthe distal end of a suture passer device such as the one shown in FIG.1E, in which the lower jaw is fixed relative to the elongate body andthe upper jaw is axially slideable distally to proximally, and the upperjaw include a suture retainer region at the distal end.

FIGS. 9A and 9B show a variation of a suture passer having a bent orcurved lower jaw (in this example the lower jaw is fixed relative to theelongate body), and an axially sliding upper jaw that is adapted todeflect the tissue penetrator from the lower jaw).

FIGS. 10A and 10B illustrate the use of a suture passer having just alower jaw with a lateral opening from which a tissue penetrator mayextend. Instead of an upper jaw that deflects and/or guides the tissuepenetrator, a separate shield or deflector may be used over the tissue.

FIG. 11 illustrates one variation of a suture that may be used, in whicha shape memory material (e.g., metal, plastic, etc.) or a materialhaving a relative stiffness may be used to help form and/or hold openthe loop of suture that is passed by the apparatus. In FIG. 11 thesuture material is a woven material that includes a shape set materialthat helps hold the bight of suture open.

FIG. 12A shows flipping of a bight of suture that has been passedthrough a target tissue (shown as a meniscus) so that the suture bightsare changed from a proximal orientation (as pushed by a suture passerthat extends distally) to be oriented distally, which may allow them tobe more easily grasped and manipulated.

FIGS. 12B and 12C illustrate upper jaw members that are adapted at theirdistal ends to pull or change the direction of the bight after it hasbeen pulled through the tissue.

FIG. 13 illustrates the use of anchors or clamps to secure the tissue tobe sutured (e.g., meniscus) so that the needle or suture passer does notshift or move the tissue undesirably during operation of the device.

FIG. 14A shows a bottom view of one variation of an upper jaw (secondjaw) having an opening into which the tissue penetrator may extend; theupper jaw is formed of a pair of leaflets with one leaflet beingdeflectable from the other so that the tissue penetrator can extendthrough the hole/opening and between the leaflets and distally out ofthe upper jaw, as illustrated in the side views of FIGS. 14B and 14C.Retracting the tissue penetrator leaves a loop or bight of suturebehind, as shown in FIG. 14C.

FIG. 15 shows a variation of the upper jaw of FIG. 14A-14C in which theleaflets forming the upper jaw may be moved laterally relative to eachother to capture and/or release a loop of suture.

FIG. 16A shows another variation of an upper jaw including a loop oropening at the distal end that may capture or retain a bight of suturepassed from the lower jaw. FIGS. 16B and 16C show bottom and side views,respectively.

FIG. 17 illustrates another variation of the distal end of a suturepasser apparatus having a suture retainer region at the upper jaw.

FIG. 18 illustrates another distal end of a suture passer apparatushaving a suture retainer region at the upper jaw as well as a deflectionregion that may be displaced relative to the rest of the upper jaw whenthe tissue penetrator extend from the lower jaw.

FIGS. 19A and 19B illustrate another variation of an upper jaw includinga suture retainer region.

FIGS. 20A and 20B show another variation of an upper jaw including asuture retainer region.

FIG. 21 shows another variation of an upper jaw including a sutureretainer region.

FIG. 22A shows another variation of an upper jaw including a sutureretainer region configured as a soft material attached to a more rigidor hard material at the distal end of the upper jaw. FIGS. 22B and 22Cillustrate similar variations.

FIG. 23 shows another variation of an upper jaw including a sutureretainer region configured as a soft material attached to a more rigidor hard material that is adapted to retain a bight of suture passed fromthe opposite jaw by the tissue penetrator.

FIGS. 24A and 24B illustrate another variation of a tissue penetratorhaving an upper jaw that is adapted to deflect a tissue penetrator andretain a bight of suture passed by the tissue penetrator to the upperjaw.

FIG. 25 shows one variation of a needle and pusher that may be used.

FIGS. 26A and 26B illustrate variation of suture passers having a distalend region that includes a bendable upper and bendable lower jaw.

FIG. 27 illustrates the operation of a suture passer apparatus having abendable lower jaw.

FIG. 28 illustrates the articulating attachment of a jaw member for usewith a bending lower and/or upper jaw member.

FIG. 29 show a hinged lower jaw and an upper jaw that may be axiallyslid (extended and/or retracted); the lower jaw may be clamped to securethe tissue between the upper and lower jaws, preventing sliding ormisfiring of the tissue penetrator.

FIG. 30 is a side view that illustrates another variation of an upperjaw having a rigid or semi-rigid region more proximal to a flexible (andnarrower) distal region. The distal region is also curved relative tothe straighter, flatter more proximal region.

FIG. 31 shows a top view of another variation of an upper jaw having apair of tensioning region that may be used to curve the upper jaw, e.g.,by pulling or pushing on the tensioning members.

FIGS. 32A and 32B show a side view and top view, respectively, of adistal end of a lower jaw member that is particularly thin (width, x),particularly as compared to the height (y), e.g., heath is more than1.5x width, more than 2x width, more than 2.5x width, etc.). FIG. 32Cillustrates a curved variation, in which the tip is curved or bent tothe left or right.

FIG. 33 illustrates another variation of a suture passer in which thelower jaw include a tissue penetrator that is not deflected out of thelower jaw by extending axially (e.g., sliding) or not exclusivelyextended by sliding, but is (at least in part) extended by pushing thedistal region of the tissue penetrator without sliding (e.g., by pullinga deflector proximally).

FIG. 34 shows one variation of a section through a distal end of asuture passer having an upper and a lower jaw in which the lower andupper jaws nest together to allow a relatively narrow profile.

FIG. 35 shows another variation of a section through a distal end of asuture passer having a distal including an upper jaw nested with a lowerjaw.

FIG. 36A shows a side perspective view of a suture passer device havinga distal end with a sliding lower jaw and a bendable (pivot able) upperjaw; a tissue penetrator may be housed within the lower jaw (which inthis variation is adapted as a pre-loaded suture containing cartridge)and may be extended from the lower jaw to the upper jaw, where it isagain deflected distally to pass a bight of suture to the upper jaw.FIG. 36B is an enlarged view of the distal end of the device with theupper jaw bent away from the long distal-to-proximal axis of the deviceand the lower jaw extended distally.

FIGS. 37A-37D illustrate another variation of a suture passer having afixed, bent lower jaw and a bendable/pivotable upper jaw, as describedabove in FIG. 9B. FIGS. 37E and 37F illustrate the operation of theapparatus in FIGS. 37A-37D. The distal end of the suture passer is shownin profile, while the tissue is shown transparent (e.g., in partialsection) to illustrate the passage of the needle and suturetherethrough.

DETAILED DESCRIPTION

In general, described herein are suture passer apparatus and methods ofmaking and using them. Any of the suture passer apparatuses describedherein may include features or elements that may be adapted for use withany of the other features or elements of the suture passers, exceptwhere specifically noted.

For example, described herein are suture passers that are particularlywell adapted for insertion and manipulation in tight, narrow anddifficult to access regions. Suture passers previously described, andillustrated in FIGS. 36A-36B, included an elongate body 3601 with aproximal handle region having controls for operating the apparatus. Thedistal end included a lower jaw member 3605 that is axially(distally-to-proximally) slideable relative to the elongate body, and anupper jaw member 3603 that is bent or bendable relative to the elongatebody and/or the lower jaw. For example, the upper jaw may be pivotablyattached 3613 to the end region of the elongate body 3601 so that itcould be bent and clamp onto tissue held between the upper and lowerjaws when the lower jaw was axially (distally) extended. A needle (alsoreferred to generically as a tissue penetrator) which can carry a sutureor loop (bight) of suture housed with the lower jaw may be extendedlaterally from a side of the lower jaw so that the tip of the tissuepenetrator extends across the jaw formed by the upper and lower jaws andcontacts the upper jaw where it is deflected distally or proximally. Thesuture may be retained by the upper jaw (or in the tissue near the upperjaw) when the tissue penetrator is retracted.

Thus, described herein are variations of suture passers that can includea laterally (axially) retractable upper jaw that may be extremely thin(e.g., less than 10 mm, less than 5 mm, less than 4 mm, less than 3 mm,less than 2 mm).

FIG. 1A shows a body of an elongate suture passer including an elongatebody extending distally from a proximal handle 105. The elongate body101 has a distal end 103 to which a first (and in some variations asecond) jaw may extend and/or be attached. The proximal handle 105 mayinclude controls for controlling the movements of the jaw(s), and tissuepenetrator. FIGS. 1B-1E illustrate various distal end configurations.For example, in FIG. 1B, the distal end includes a lower jaw member 107that is configured to slide axially distally and proximally relative tothe elongate body (e.g., in line with the elongate body). The upper jaw109 is also configured to slide distally and proximally from within theelongate body to form a distal-facing (v-shaped) opening surrounding thetissue to be sutured. In FIG. 1B, the upper jaw is thin and acts as aprotective member that prevents the tissue penetrator 115 (shownextended in FIG. 1B) from extending across the jaws and into theopposite side; instead, the tissue penetrator 115 is deflected distallyalong the bottom of the upper jaw member 109.

The upper jaw in the variation shown in FIG. 1B is similar to that shownin FIG. 1B, however the lower jaw member 113 does not move axially, butis instead fixed, and may be integral with, the elongate body. The lowerjaw 107 in FIG. 1D is similar to the lower jaw of FIG. 1B, however, theupper jaw 111 includes a suture capture region 119 (which may also bereferred to as a suture retainer, trap, suture capture, or suture snare)at or near the distal end region. The tissue penetrator 115 extendingfrom the lower jaw member passes through the upper jaw 111 so that itextends out of the distal end of the upper jaw; when the tissuepenetrator is retracted back into the lower jaw 107, a suture beingpushed through the tissue by the tissue penetrator from the lower jawmember will remain held by the suture retainer 119 in the upper jaw 111.Any appropriate suture retainer may be used. Examples of suture retainerregions are described below, and may include a leaf-spring region thatis displaced by the tissue penetrator as well as edge (e.g., jagged)regions that may trap and/or hold the suture.

FIG. 1E also shows a side perspective view of a distal end of a suturepasser as described above, having a lower jaw member that is fixed andextends from the distal end of the elongate body, and an upper jawmember that is axially slideable and include a suture retainer region119.

The variations shown in FIGS. 1B-1E are suture passers with very thinupper jaws (e.g., the upper jaw may be less than 2 mm thick, less than 1mm thick, less than 0.5 mm thick, etc.). When used in knee meniscusrepair, the primary purpose of this upper jaw is to protect condylesurfaces from the needle that comes out of the lower jaw. Protection ofthe condyle is achieved by having the thin upper jaw be hard enough todeflect the needle. The upper jaw may be sufficiently bendable to curveand bend away from the lower jaw as it is extended out of the elongatebody, as illustrated. For example, the upper jaw may be formed of ashape memory material such as Nitinol.

FIGS. 2A-2E illustrate the distal end variation shown in FIG. 1B inoperation. To position the tissue penetrator around a target tissue, thelower jaw member 207 may be first extended distally from the distal endof the elongate body, as shown in FIG. 2A. Thereafter, or before thelower jaw has been completely extended, the upper jaw 209 may beextended from the distal end of the elongate body, as shown in FIG. 2B.In FIG. 2C, both the upper and lower jaws have been fully extendedaround a target tissue (e.g., the meniscus in a knee). Thereafter, asshown in FIG. 2D, the tip of the tissue penetrator 215 housed completelywithin the lower jaw may be extended from the lower jaw, though thetissue and against the upper jaw, where the tip is deflected distally. Asuture, e.g., a loop or bight of suture, may be include and may bepassed with the tissue penetrator from the lower to the upper jaw.

FIGS. 3A-3E illustrate the operation of a distal end of suture passersimilar to the variation shown in FIG. 1C, having a rigidly fixed lowerjaw 213. The extended lower jaw 213 may be positioned within the tissue,e.g., on one side of the target tissue, and typically has a narrow andthin profile, allowing it to be positioned within the tissue and intoeven difficult to access regions. As described below in reference toFIGS. 9A and 9B, the lower jaw may be bent (or in other variations,bendable). In FIGS. 3A-3E the lower jaw does not slide distally orproximally relative to the elongate body; instead, only the upper jaw209 slides distally and proximally. In FIG. 3B, the upper jaw 209 isshown extended distally. FIG. 3C shows the upper jaw fully extended andthe tissue penetrator is then extended across the tissue as shown inFIGS. 3D-3E.

FIGS. 4A-4F illustrate the operation of one variation of a tissuepenetrator as described above. The distal end of the tissue penetratorillustrated in FIGS. 4A-4F has a fixed lower jaw 407 that is rigidlyconnected to the distal end region of the elongate body, and a thin,strong, upper jaw deflector 409 can be extended distally by sliding outof the elongate body and curving up slightly as it extends outward. InFIG. 4A, the lower jaw member may be positioned on one side of themeniscus, and the upper jaw member may be extended from the distal endof the elongate body (the proximal end of the lower jaw member), asshown in FIG. 4B. In FIG. 4C, the tissue penetrator 415 is extendedacross and though the meniscus 414 between the upper and lower jaws,passing a loop (bight) of suture though the meniscus along with thetissue penetrator. The tissue penetrator (needle) and suture are passedthrough the meniscus. The tissue penetrator deflects off the upper jawaway from the femoral condyle and carries a bight of suture beyond thesuperior surface of the meniscus. In FIG. 4D the tissue penetrator hasbeen retracted, leaving the first bight of suture through the meniscusand between the superior surface of the meniscus 417 and the femoralcondyle 419. The tissue penetrator is retracted, leaving behind thesuture bight (the friction between the needle hole through the meniscusand the suture retains the suture as the needle is retracted). Thesuture passer may then be repositioned around the tissue, loaded withthe second bight of suture (which may be, for example, the opposite endof the suture forming the first loop) and against passed through thetissue, as shown in FIG. 4E. The suture passer has been moved to a newlocation, and another bight of suture is passed through the meniscus inthe same manner as shown in FIGS. 4C and 4D. Once the suture passer isremoved, the two bight regions extending through the meniscus may begrasped and pulled and/or knotted (e.g., to each other) to secure thetissue, as shown in FIG. 4F. For example, the suture passer may bepulled away from the suture bights, leaving the suture bights inlocation through the meniscus. A second tool is then used to retrievethe suture bights. Such a tool could be a hook, a crab claw, etc. Insome variations a hook or grasper may be used, including an upper jawhaving a hook region allowing it to grip and manipulate the sutureloops, as illustrated in FIG. 5. In FIG. 5, a hook feature exists at theend of the upper jaw, allowing the suture passer upper jaw to be thetool used to retrieve the suture bights.

The method shown in FIGS. 4A-4F illustrates operation of a device havingan upper jaw without a suture trap (suture capture region). In somevariations, the lower jaw may also be fixed (e.g., does not slideaxially relative to the elongate shaft/body) to facilitate a deviceshaft that is as thin as possible by eliminating internal features thatallow for a sliding lower jaw.

In any of the variations described herein, the upper and lower jaws ofthe suture passer may be adapted to clamp, gab, grasp or otherwise holdsecure the tissue between the upper and lower jaw to prevent it fromtearing during the procedure, and from moving when the tissue penetratoris applied against the tissue. This may reduce misalignment of needle asit is passed through the tissue.

Thus, any of the devices described herein may be adapted to include aclamping element, such as a sleeve, tube, etc., that drives or allowsthe distance (e.g., angle) between the upper and lower jaws to bereduced. For example, in FIGS. 6A-6C, an outer cannula 603 (e.g.,sleeve) may be driven distally to push against the outer sleeve, causingthe thin, and somewhat flexible upper jaw member 601 to close towardsthe lower jaw 611, as shown in the progression from FIGS. 6A-6C.Similarly, moving the sleeve/cannula proximally allows the upper jaw toexpand up and away from the lower jaw, further opening the distal-facingopening.

In FIGS. 6A-6C, the thin upper jaw is shown as an upper jaw that can beadvanced and retracted from the device shaft, perhaps telescopically,while the lower jaw is fixed relative to the distal end of the elongatebody. Having the upper jaw retracted allows the device to be easilyinserted into the joint, and in the case of the knee, may allow thelower jaw to be easily inserted underneath the meniscus. Then, due toits thinness, the upper jaw can readily be advanced above the meniscus.The clamping mechanism (cannula or sleeve) that is shown in FIGS. 6A-6Cas a tube. As mentioned, by advancing the clamping mechanism, the upperjaw clamps down on the lower jaw, compressing any tissue between theupper and lower jaws. Retracting the tube allows the clamp to bereleased.

FIGS. 7A-7E illustrate the operation of the suture passer device havinga sliding upper and sliding lower jaw that may both be independentlyslide (axially) into and out of the distal end region of the elongatebody to form a v-shaped distal opening, as described above for FIG. 1D.In this example, the upper jaw 701 is thin, but includes a sutureretainer region 703 at the distal end portion of the upper jaw. Toposition the device, the lower jaw 705 may be extended from the distalend of the elongate body and slide under or adjacent to a target tissue.The upper jaw may then be extended out of the distal end of the elongatebody and extend across the target tissue from another side. Once thetissue is held between the jaws, as shown in FIG. 7C, a needle (tissuepenetrator) may be extended from the lower jaw toward the upper jaw, asshown in FIG. 7D. The needle may be a bendable, yet sharp, member havinga sufficient column strength to be pushed through tissue while carryinga suture (e.g., in a hook, eye, or other portion at or near the distalend of the tissue penetrator). For example, a tissue penetrator may be astainless steel or Nitinol material that is extended distally in thelower jaw until it is deflected at the lateral opening in the lower jawto direct the tip of the tissue penetrator out of the lower jawlaterally at nearly 90° relative to the long axis of the lower jaw. Inthe example shown in FIG. 7E, the tip of the tissue penetratoreventually contacts the upper jaw 701, where it is deflected by theupper jaw and directed distally (although as mentioned, it could bedirected proximally). The tissue penetrator in FIG. 7E passes through achannel, or opening that is configured as a suture retainer/trap 703.The suture retainer catches and holds the suture (e.g., sutureloop/bight) when the tip of the tissue penetrator is retracted back tothe lower jaw (not shown).

FIGS. 8A-8E illustrate a similar mechanism of operation for a suturepasser such as the suture passer distal end region shown in FIG. 1E. InFIGS. 8A-8E, as in FIGS. 7A-7E, the upper jaw 801 includes a sutureretainer/trap 803, however in FIGS. 8A-8E the lower jaw 805 is fixed(e.g., does not slide) relative to the upper jaw.

Any of the suture passers described herein may include a bend orbendable region in an upper or lower jaw to help position the distal endof the device in even narrow and constrained regions of a tissue such asa knee or shoulder joint. For example, FIGS. 9A and 9B illustrate anapparatus having a lower jaw that is fixed relative to the more proximalelongate body from which the lower jaw 901 extends. As shown in theprofile view of FIGS. 9A and 9B, the fixed lower jaw 901 is angled orcurved relative to the elongate body region 905 of the apparatus. Thevery thin upper jaw 903 is configured as a deflector for a tissuepenetrator, as mentioned above, and, in some embodiments, can beadvanced and retracted into the elongate body 905. In other embodiments,the very thin upper jaw 903 is fixed (e.g., does not slide) and/orpivoting relative to the lower jaw and the elongate body. The angled orcurved lower jaw is intended to provide a shape that provides easieraccess in tight joints. As explicitly mentioned above, any of the suturepasser apparatuses described herein may include features or elementsthat may be adapted for use with any of the other features or elementsof the suture passers, except where specifically noted. For example, thebent lower jaw of FIG. 9B may be used with a pivoting upper jaw asillustrated in FIGS. 36A-36B. FIG. 37 provides another example of adevice having a pivoting upper jaw and a bent lower jaw.

In general, the upper (or second) jaw is configured to deflect thetissue penetrator that laterally exits from the distal end region of thelower jaw at an angle (e.g., an angel between 60-125 degrees, relativeto the long axis of the lower jaw and/or the long axis of the elongatebody). However, in some variations an integrated upper jaw/deflector isnot included, but instead a separate shield/deflector member may beused. FIGS. 10A and 10B illustrate the use of a separate shield 1001with a “one armed” suture passer 1005. In FIGS. 10A and 10B, a kneejoint including a femoral condyle 1007 is shown. The shield may beinserted before the procedure is performed, and is a protective shield1001 that is placed between the femoral condyle 1007 and the meniscus1009 prior to suture passing. After placing the shield, the suturepasser 1005, the distal end of which consists of only a shaft and fixedlower jaw, is slid underneath the meniscus 1009. The tissue penetratorand suture are then passed from the lower jaw, through the meniscus, andthen the tip of the tissue penetrator deflects off of the shield awayfrom the femoral condyle. The simplicity of the suture passer apparatusin his example (without a second jaw member) may allow the size of thedevice to be minimized.

All of the methods and apparatuses described herein typically includethe use of a suture. An appropriate suture may be used. For example,braided or monofilament suture, and/or sutures of any appropriatematerial, including bioabsorbable materials (e.g., polymeric materials).It may be of benefit to make the suture bight self-expanding or opening,to allow the suture bight to be more easily captured by a tool, or insome variations by the second/upper jaw. For example, if the apparatusdoes not include a suture capture region (e.g., on the second or upperjaw member), a self-expanding suture may be more easily captured if thebight is opened on the superior surface of the meniscus after suturepassing; this may make it easier to retrieve with a tool. As shown inFIG. 11, the suture forming the suture bight may include a shape setmaterial (e.g., Nitinol wire) within or on the suture. For example, thesuture may include an over-braid having a shape-set wire within thebraid. When the bight exits the meniscus after suture passing, the wireexpands to create a large open loop that provides an easy target for aretrieval tool.

The orientation of the loop within the tissue may also be adjusted bythe apparatus to make it easier to retrieve. For example, FIG. 12Aillustrate a method of orienting the loop of a bight so that the loop ismore easily accessible by a tool accessing the tissue from the samedirection as the suture passer. In FIG. 12A, the suture is flipped froma distal (e.g., away from the entry point of the apparatus in thetissue) to a proximal (towards the entry point of the apparatus into thetissue) orientation. FIGS. 12B and 12C illustrate variations ofapparatuses that are adapted to flip the suture bight proximally to makethe bight easier to retrieve. When the upper jaw is retracted (after theneedle has been retracted), the distal end of the upper jaw may pull onthe suture bight and flip it proximally. For example, in FIG. 12B theupper jaw includes a large opening though which the tissue penetrator,and therefore the suture bight left behind upon removal of the tissuepenetrator, passes. The loop (shown as a hook in FIG. 12C) pulls thebight distally before passing over the bight as the upper jaw isretracted proximally, similar to what is shown in FIG. 12A.

Any of the variations described herein may be used with one or moreanchors to hold or secure the target tissue relative to the apparatuswhen suturing. For example, in particular, when the suture passingapparatus is not adapted to clamp or hold of secure the portion of thetissue around the suture, the tissue (e.g., meniscus) may move when theneedle begins to penetrate. This unintended movement may cause theneedle to deflect/buckle, resulting in a misfire of the suture passer.In FIG. 13, temporary clamps 1305, 1306 are placed on the meniscus tofix the meniscus and prevent any motion of the meniscus. After placingthe clamps the suture passing system can be introduced to pass suture.Another potential benefit of the clamp could be alignment markers, whichare used to align the device to the clamp to facilitate precisetargeting of the needle and suture passing. The clamps are then removedafter the suture is placed. The clamps can also have mating featuresthat facilitate docking of the suture passer to the clamp. Thisconfiguration of suture passer and temporary clamp could allow forsuture positioning to be less sensitive to device or tissue movementduring suture placement.

As mentioned above, any of the thin, sliding upper jaws may include asuture capture (e.g., “trap”) that holds the suture in the upper jaw asthe tissue penetrator is retracted proximally back into the lower jaw.FIGS. 14A-14C show one variation of an upper jaw having a suture captureformed by two layers of material. In FIG. 14A, a bottom view of theupper jaw shows the thin upper jaw having two layers. The top layer 1401is solid and hard enough to deflect the needle away from condylesurfaces. The bottom layer 1403 is flexible and provides a spring forceup against the top layer. In the bottom view of FIG. 14A, the bottomlayer 1403 includes a window region 1407 for the tissue penetrator topass through and then deflect off of the top layer 1401. The tissuepenetrator and suture then penetrate between the distal tips of the twolayers and travel beyond the distal tips. This is illustrated in FIG.14B (showing the tissue penetrator 1414 between the two layers carryinga suture 1417). In FIG. 14C, when tissue penetrator is retracted, thespring force between the two layers grips and retains the suture 1417bight beyond the tip of the upper jaw. Therefore, when the device isremoved from the joint the suture bight is trapped by the upper jaw andis pulled from the tissue. To enhance the suture retainer, either of thelayers could have teeth on them.

In another embodiment of FIGS. 14A-14C, the upper jaw is retractable andas it is retracted, the lower layer of the upper jaw may retract fartherthan the top layer; as a consequence, the suture bight may be cinchedbetween the two layers, trapping the suture and allowing the suturebight to be removed from the joint with the device. This is illustratedin FIG. 15.

FIGS. 16A-16C illustrate another variation of an upper jaw having asuture retainer. In FIGS. 16A-16C, the upper jaw includes two piecesthat are in the same plane, to minimize thickness and the relativemotion between the pieces. The outer piece 1601 cinches to the innerpiece 1603 to cinch down on the suture. Alternatively, a one piece upperjaw with a window could be retracted into the shaft to “snare” thesuture. A window in a one piece thin upper jaw may include snaringfeatures that could assist in catching and holding onto the suture asthe upper jaw is retracted into the shaft. In FIG. 17, the snare featureand window are slightly lower than the deflective surface of the upperjaw for the purpose of ensuring that the needle passes through thewindow.

FIG. 18 illustrates another variation of a suture retainer on the upperjaw. In FIG. 18, an upper jaw with a snaring feature 1803 also has aleaf spring region 1805 that deflects slightly when the needle hits it.This deflection helps to ensure that the needle and suture travelthrough the window and above the snaring feature.

Alternatively, in some variations the distal end of the upper jaw membermay be adapted (e.g., by doubling back over itself) to form acompression region that may be displaced by the tissue penetrator,rather than requiring a separate layer. The very distal end region mayinclude an opening or passage for the tissue penetrator to continue toextend distally past the distal end of the upper jaw, or distal movementof the tissue penetrator may be prevented by the bend formed in theupper jaw. FIGS. 19A-19B and 20A-10B illustrate variations of upper jawsthat include a suture retainer formed by doubling the material formingthe upper jaw back onto itself.

In FIG. 19A, the distal end region forms a suture capture or “trap” inthe thin upper jaw. The suture traps 1903, 2003 on the distal endprovides a spring force to retain the suture from the tissue penetrator1905, 2005. FIGS. 19A and 20A show alternate embodiments of springmechanisms that could trap the suture onto the upper jaw when retractingthe tissue penetrator. In FIGS. 19A-20B, these suture traps in the upperjaws have windows at the distal end to allow the needle to pass throughthe trap and leave a suture bight distal of the trap. FIG. 21illustrates another variation of a suture capture (suture trap) thatalso clamps (or springs) down to nest over the lower jaw and create asmooth profile for inserting the device into the tissue.

In some variations, the upper jaw includes a suture capture region thatis formed of a material that can be penetrated by the tissue penetratorbut that provides sufficient friction to retain the suture when thetissue penetrator is withdrawn from the upper jaw member. For example,FIGS. 22A-22C illustrates a thin upper jaw with two layers, a hard upperlayer 2201 that deflects the needle and a soft lower layer 2203 (forexample, silicone) that the tissue penetrator (e.g., needle) canpenetrate and travel through. When the needle is retracted, the softlower layer would apply friction to the suture to retain the suturebight in the upper jaw. FIG. 22B shows a variation including the softmaterial 2203 just at or near the distal end of the device; the materialmay provide a soft and/or slippery surface to prevent damage to thetissue into which the upper jaw is inserted. In FIG. 23C, the softmaterial 2203′ (for example, silicone) forming part of the suture trapat the end of the upper jaw is intended to be penetrated by the tissuepenetrator that can pass through the soft material forming the suturetrap, and when the needle retracts, the suture bight is retained in thesuture trap. The cross section of the upper jaw (shown in the inset ofFIG. 22C) could have rails 2209 on the side to guide the tissuepenetrator into the suture capture trap.

FIG. 23 illustrates another variation of a suture capture that is formedby a soft material. In the upper jaw of FIG. 23, there are two layers, ahard upper layer 2301 and soft lower layer 2305. However, in thisembodiment the hard upper layer 2301 deflects slightly when the tissuepenetrator 2307 hits it, encouraging the tissue penetrator to passbetween the two layers. When the needle retracts, the pinch forcebetween the hard and soft layer retains the suture in the upper jaw.

FIG. 24A illustrates two concepts for upper jaws including suturecapture. In both concepts, the upper jaw/needle combination deflects theneedle proximally. In the first concept, a second deflecting feature isintended to deflect the needle back down to the lower jaw where a suturetray may exist. In the second concept, the needle continues to travelproximally toward the upper jaw hinge region where a suture trap exists.

In FIG. 24B, similar to that shown in FIG. 24A, a tissue penetrator thatis deflected proximally and back down to the lower jaw picks up suturein the lower jaw. This concept could result in a continuous suturepasser. With one pass, the tissue penetrator drops off the suture in thelower jaw, and a second tissue penetrator pass can then pick up thesuture, etc.

As mentioned above, any of the apparatuses described herein may be usedwith any appropriate tissue penetrator (e.g., needle). In general, thetissue penetrator may be an elongate, thin and sharp (at the distal end)apparatus that is adapted to pass a suture, and may include a sutureretainer region, such as an eyelet, hook, clamp, etc. In general, atissue penetrator is coupled at the proximal end within the lower jaw sothat it can be extended and retracted, e.g., by pushing/pulling on theproximal end. FIG. 25 illustrates one variation of a tissue penetratorthat is shuttled between the lower and upper jaw. The tissue penetratorhas features on the proximal end that allow the lower jaw to release thetissue penetrator so that the tissue penetrator and suture can dock inthe upper jaw.

FIGS. 26A and 26B illustrate examples of upper and lower jaws thatarticulate to allow the suture passer to conform to the anatomy thatsuture passer is operating in. Thus, in these examples, both the upperand lower jaws may pivot relative to the elongate body to change theangle.

In FIG. 27, the lower jaw is adapted to pivot (e.g., upwards). This maybe advantageous in the confines of the knee when accessing a meniscus,since the shaft is often entering the joint at an angle to get above theanterior portion of the meniscus. Thus, a pivoting lower jaw may provideeasier access in tight joints. The lower jaw 2701 in FIG. 27 may beadapted for use in a suture passer such as the variation shown in FIGS.36A-36B, having a sliding lower jaw member housing a tissue penetratorand a pivoting upper jaw. The tapered lower jaw may be adapted to slidewithin a keyway in the shaft to allow the lower jaw to advance/retractin addition to pivoting upwards. FIG. 27 demonstrates how having a lowerjaw with an upwardly bent angle or hinge may be beneficial in placingthe distal end of the suture passer when the access portal into thejoint must be placed above the anterior horn of the same meniscus to berepaired. The portal above the meniscus may force an approach vectorthat is pointing downward at the tibial plateau. However, when the lowerjaw is placed inferior to the meniscus, it may be easier to get it inplace if the lower jaw traverses parallel with the tibial plateau. InFIG. 28, a lower jaw could advance/retract and pivot in an upwardly (ordownwardly) curved shaft where the keyway is also curved.

FIG. 29 illustrates a side view of a device with a very thin,extendable/retractable upper jaw with a lower jaw that clamps. Thus, thelower jaw may house the sliding tissue penetrator but may also beadapted to pivot and therefore clamp tissue between the upper 2903 andlower jaws 2901. The upper jaw may be similar to the upper jaws shown inFIGS. 1B-1E (e.g., may be thin and configured to deflect the tissuepenetrator). In addition to improved access, the clamping lower jaw 2901feature may mitigate the challenge of the movement of meniscus as thetissue penetrator begins to penetrate the meniscus. The clampingmechanism could be facilitated by tensioning a cable or a linkage.

Another variation of the configuration for the upper jaw is shown inFIG. 30. In this example, the upper jaw may be configured as a clampingupper jaw (e.g., see the variation shown in FIGS. 36A-36B) with a rigidsection and a flexible section. Both sections may have hard elements onthe inferior surface that could deflect the needle away from non-target(e.g., condyle surfaces). The rigid section may provide a clampingregion of the upper jaw. The end of the rigid section may correspondwith the end of the tooth on the lower jaw to maximize the effectivenessof the clamp. The inferior surface of the clamping region may bestraight to maximize clamp effectiveness and the superior surface iscurved to maximize access. The flexible section may be thin and flexibleto conform to the anatomy and maximize access. The flexible section mayalso be coated with a soft material to facilitate atruamatic insertionbetween the femoral condyle and the meniscus.

In general, the upper jaws for a suture passer apparatus may be adaptedto bend or flex, as mentioned. In some variations this bending orflexing may be controlled. For example, FIG. 31 illustrates the distalend region of one variation of an upper jaw member (deflector jaw). InFIG. 31 the upper jaw is a one piece, very thin upper jaw (shown in atop view). The central strut of the upper jaw is fixed at the proximalend (e.g., at the bottom in FIG. 31). When the two outer struts arepulled in tension, the central strut bows upward, providing a downwardclamp force for the upper jaw. When the two outer struts are compressed,they bow downwards and the upper jaw lifts upwards. This variation maybe included as part of a sliding upper jaw or as part of a pivotingupper jaw.

FIGS. 32A and 32B illustrate variations of the lower jaw that may beused. In FIGS. 32A and 32B, the narrow width lower jaw (compared to theheight) may be particularly useful in variations of suture passers suchas those shown in FIGS. 1B-1E. In FIGS. 32A and 32B, the lower jaw witha narrow width and a height necessary to eject the tissue penetratoralong the desired trajectory path. The advantage of the narrow width isthat it allows the user to gain access in tight joints by rotating thedevice sideways. Once the device is in position, the device can berotated back to fire the needle through the meniscus. FIG. 32C showsanother embodiment of the above concept, in which the lower jaw iscurved to one side, as shown. When a device having a curved lower jaw isrotated sideways for insertion, there is an upward bend to allow foreasier access. Once the device is in position, the device can be rotatedback to fire the tissue penetrator through the tissue. In variationshaving an upper jaw, the upper jaw may be curved in a complimentarydirection.

As discussed above, in general, the tissue penetrator is adapted toextend from the lower jaw by sliding the tissue penetrator distally.However in some variations the lower jaw may extend the tissuepenetrator by instead driving a deflection member proximally or distallyto push the tissue penetrator. For example, in FIG. 33, a lower jaw maybe made relatively thin (in height) as it does not require a passiveneedle channel that directs the needle vertically, but instead a cam maybe actuated (e.g., pulled proximally) to bend a metal sheet/strip toactively form the tissue penetrator channel that will direct the tissuepenetrator vertically.

In any of the suture passer variations described herein, the jaws(lower/upper, first/second, etc.) may be arranged in reverse (e.g., the“upper” jaw may be positioned in a “lower jaw” position and vice versa.

The overall distal end of the device may be adapted to be narrower orthinner by nesting the upper and lower jaws. For example, FIG. 34illustrates nesting the upper and lower jaw together to create a lowprofile for entering the joint space. Similarly, FIG. 35 illustratesanother nesting concept to create a low profile for entering the jointspace. The lower jaw is in the center; the upper jaw is the outerfeature.

FIGS. 36A and 36B illustrate a suture passer apparatus such as thevariation described in Patent Application Publication Nos. US2012/0283753 and US 2013/0331865, and WO 2014/145381 each of which isherein incorporated by reference in its entirety. In FIG. 36A, forexample, the distal end of the suture passer apparatus includes ahinged, pivoting upper jaw 3602 that pivots relative to the elongatebody 3607. A sliding lower jaw 3605 houses a tissue penetrator (notvisible in FIG. 36A or FIG. 36B) that can be extended laterally acrossthe distal-facing opening formed by the upper 3602 and lower 3605 jawswhen they are extended. The proximal handle 3611 includes multiplecontrols for controlling the motion of the upper jaw, the lower jaw andthe tissue penetrator. In this example, the lower jaw is pre-loaded as acartridge with suture. Any of the apparatus variations described hereinmay be adapted to include pre-loaded suture, including variations inwhich the lower jaw is fixed, pre-bent, and/or slideable.

FIGS. 37A-37D illustrate another variation of a suture apparatus similarto the one shown in FIG. 9B, while FIGS. 37E and 37F illustrate theoperation of the apparatus of FIGS. 37A-37D. In this example, the lowerjaw 3702 is bent near the proximal end of the lower jaw 3707. The upperjaw 3704 is pivotable relative to the elongate body 3706 (only thedistal end of which is visible) and the lower jaw 3702. In FIG. 37A, theupper 3704 and lower 3702 jaws are shown “open” so that a target tissue(e.g., knee meniscus) can be positioned within the distal-facingopening; the upper jaw 3704 may be pivoted opened even further thanshown. In this example, the location of the bend 3707 in the lower jawis slightly distal to the proximal end of the lower jaw; in somevariation the bend may be more proximally located, so that the lower jawbends before the pivot point 3709 (e.g., pin, hinge, etc.) of the upperjaw. As shown in this example, the lower jaw is continuous and formedwith the distal end region of the elongate body 3706; in some variationsthe lower jaw may be discrete and separate from the elongate body. Thepivot point of the upper jaw may be connected to the elongate body, orit may be connected to the lower jaw.

The lower jaw may generally be configured to fit within the targetanatomy (e.g., meniscal region of the knee). For example, the lower jawmay be configured so that it is bent at a predetermined angle, asmentioned above. Angles between about 2 degrees (e.g., 5 degrees, 10degrees, etc.) and about 45 degrees (e.g., 40 degrees, 35 degrees, etc.)relative to the elongate body may provide convenient approach angleswhen operating in the meniscal region. In addition, the bottom of thelower jaw maybe configured to be straight and flat from the bend 3707towards the distal end region 3716. This may allow the bottom jaw toconform the region between the inferior surface of a meniscus and thetibial plateau. In addition or alternatively, the distal end region maybe generally curved (e.g., atraumatic) or rounded, as shown in FIGS. 9Band 37A-37F.

In general, the upper jaw member may be closed against the lower jawmember, as shown in FIG. 37B. In this example, the upper jaw 3704 ishinged relative to the lower jaw 3702 so that is can be closed as shown.In some variations a control on the proximal handle (see, e.g., FIG.36A), such as a distal lever 3625 may be used to open/close the upperjaw. For example, squeezing this first control may close the upper jawtowards the lower jaw. The upper jaw and/or the control may be biasedrelative to the handle, so that it is normally in an open position andthe handle is actuated to close it (or vice-versa). The device mayinclude a lock to hold the upper jaw in a particular open/closedposition.

FIG. 37C illustrates the actuation of the tissue penetrator 3720 so thatit is deflected out of the lower jaw, lateral between the jaws and into(and through) the upper jaw, as shown in FIG. 37D. The tissue penetratormay be similar to any of the tissue penetrators previously described,and may include a sharp distal end (which may be pointed), and may belong and flat, as shown, and described above in FIG. 25C. The distal endregion may also include a suture holding/capture region, such as alateral cut-out region that extends generally proximally, so that theloop of suture may be driven into the cut-out region when extending fromthe lower to the upper jaw, but may be released from the cut-out regionwhen retracting back into the lower jaw. In general, the distal end ofthe elongate tissue penetrator may extend between the jaws while aproximal end of the tissue penetrator is still held within the lower jaw(and the elongate body region). Thus, the tissue penetrator must bend atleast twice, e.g., simultaneously, once at the bend region within thelower jaw and once at the deflection region 3714 near the distal end ofthe lower jaw.

As shown in FIG. 37D, the tissue penetrator 3720 may generally passthrough (and laterally out of) the upper jaw at a pass-through region3724, which may also include a suture retainer, such as a suturestripper or stripping region (e.g., a plate or other leaf-spring region)that retains the suture loop 3744, as illustrated in FIGS. 37E and 37F.For example, in FIG. 37E the tissue penetrator is extended from thelower jaw, up through the target tissue (a meniscus 3735) and though theupper jaw, while pushing a loop of suture 3744. As shown in FIG. 37F,the loop 3744 may be retained in the upper jaw when the tissuepenetrator is retracted back down in to the lower jaw. To complete thestitch, the suture passer device may be removed from the tissue, whilethe ends of the loop of suture 3746 may be pulled or held, so that theloop is pulled from the upper jaw. In some variations, the loop may beactively dislodged by a mechanism.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements, these features/elements should not be limitedby these terms, unless the context indicates otherwise. These terms maybe used to distinguish one feature/element from another feature/element.Thus, a first feature/element discussed below could be termed a secondfeature/element, and similarly, a second feature/element discussed belowcould be termed a first feature/element without departing from theteachings of the present invention.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A suture passer apparatus adapted for insertioninto a knee joint, the apparatus comprising: an elongate body having aproximal end connected to a proximal handle and a distal end region,wherein the elongate body extends in a long axis; a lower jaw memberextending from the distal end region of the elongate body wherein thelower jaw member is axially fixed relative to the elongate body, thelower jaw member including a bend relative to the long axis of theelongate body at a proximal end of the lower jaw member, wherein abottom surface of the lower jaw member from the bend to a rounded distalend region of the lower jaw member is flat and extends in a straightline to the rounded distal end region; an upper jaw member extendingfrom the distal end region of the elongate body, the upper jaw memberhaving an arc-shaped profile that is biased to curve away from the longaxis of the elongate body in a same direction as the bend, and whereinthe upper jaw member has a retracted configuration in which the upperjaw member is entirely within the elongate body; and a tissue penetratorhoused within the lower jaw member configured to slide distally in thelower jaw member beyond the bend and extend laterally out of the lowerjaw member to transfer a loop of suture from the lower jaw memberthrough the upper jaw member.
 2. The apparatus of claim 1, wherein thebend is at an angle that is between 5 degrees and 40 degrees relative tothe long axis of the elongate body for inserting the lower jaw memberinto the knee joint.
 3. The apparatus of claim 1, wherein the tissuepenetrator is a thin, flat and elongate Nitinol member.
 4. The apparatusof claim 1, wherein the upper jaw member is configured to move from theretracted configuration to an extended configuration to axially alignwith the lower jaw member with respect to the long axis, engage tissueand receive the loop of suture and the tissue penetrator.
 5. Theapparatus of claim 1, wherein the upper jaw member comprises a suturecapture region adapted to receive the loop of suture on the upper jawmember when the tissue penetrator is retracted proximally aftercontacting the upper jaw member.
 6. The apparatus of claim 1, whereinthe upper jaw member comprises a suture capture comprising a clampingmember.
 7. The apparatus of claim 1, wherein the lower jaw membercomprises a deflection surface within the lower jaw member to deflectthe tissue penetrator laterally out of the lower jaw member when thetissue penetrator is slid distally.
 8. The apparatus of claim 1, whereina thickness of the lower jaw member is less than a width of the lowerjaw member over a majority of the lower jaw member.
 9. A suture passerapparatus adapted for insertion into a knee joint, the apparatuscomprising: an elongate body having a proximal end connected to aproximal handle and a distal end region, wherein the elongate bodyextends in a long axis; a lower jaw member axially fixed to the distalend region of the elongate body, the lower jaw member including a bendof between 5 degrees and 40 degrees relative to the long axis of theelongate body at a proximal end of the lower jaw member, wherein abottom surface of the lower jaw member from the bend to a rounded distalend region of the lower jaw is flat and extends in a straight line tothe rounded distal end region; an upper jaw member configured to moveaxially from a retracted position in which the upper jaw member isentirely within the elongate body to an extended position in which theupper jaw member is extended from the elongate body, wherein the upperjaw member is biased to curve away from the long axis of the elongatebody in a same direction as the bend as it is moved to the extendedposition; and an elongate, thin and flat tissue penetrator housed withinthe lower jaw member configured to slide distally in the lower jawmember beyond the bend and extend a distal tip region laterally out ofthe lower jaw member to transfer a loop of suture from the lower jawmember, through a tissue and through the upper jaw member.
 10. A methodof suturing tissue, the method comprising: inserting a suture passerinto a body region, wherein the suture passer is loaded with a loop ofsuture in a lower jaw of the suture passer, wherein the suture passercomprises an elongate body extending in a long axis, an upper jawcoupled to the elongate body, the upper jaw comprising an arc-shapedprofile and a retracted position in which the upper jaw is completelyretracted within the elongate body; and wherein the lower jaw is coupledto a distal end region of the elongate body, the lower jaw including abend relative to the long axis of the elongate body at a proximal end ofthe lower jaw, wherein a bottom surface of the lower jaw from the bendto a rounded distal end region of the lower jaw is flat and extends in astraight line to the rounded distal end region; positioning a targettissue adjacent to the lower jaw while the upper jaw is in the retractedposition; extending the upper jaw from the elongate body so that thetarget tissue is straddled and captured between the lower jaw and theupper jaw, wherein the arc-shaped profile is biased to curve away fromthe long axis of the elongate body in a same direction as the bend inthe lower jaw as the upper jaw is extended; closing the lower jaw andthe upper jaw to at least partially clamp the target tissue between thelower jaw and the upper jaw; and pushing a distal end region of a tissuepenetrator from within the lower jaw to deflect laterally out of thelower jaw through the target tissue and through the upper jaw, whereinthe distal end region of the tissue penetrator is carrying the loop ofsuture.
 11. The method of claim 10, wherein positioning the targettissue adjacent to the lower jaw comprises positioning a torn kneemeniscus adjacent to the lower jaw.
 12. The method of claim 10, whereinpositioning the target tissue adjacent to the lower jaw comprisessliding the lower jaw under an inferior surface of a knee meniscus, themethod further comprising extending the upper jaw from the retractedposition until the upper jaw is adjacent the superior surface of theknee meniscus.
 13. The method of claim 10, further comprising loadingthe loop of suture into the lower jaw by loading the loop of suture intothe distal end region of the tissue penetrator.
 14. The method of claim10, wherein closing the lower jaw and the upper jaw comprises squeezinga first control on a proximal handle of the suture passer.
 15. Themethod of claim 14, wherein pushing the distal end region of the tissuepenetrator from within the lower jaw to deflect laterally out of thelower jaw through the target tissue and through the upper jaw comprisessqueezing a second control on the proximal handle of the suture passer.16. The method of claim 10, wherein pushing the distal end region of thetissue penetrator from within the lower jaw to deflect laterally out ofthe lower jaw through the target tissue and through the upper jawcomprises retaining a proximal portion of the tissue penetrator withinthe lower jaw as the distal end region of the tissue penetrator isextended through the upper jaw.
 17. The method of claim 10, furthercomprising stripping the loop of suture from the tissue penetrator andretracting the tissue penetrator back into the lower jaw, wherein theloop of suture is retained on the upper jaw after retracing the tissuepenetrator back into the lower jaw.
 18. The method of claim 10, whereinpushing the distal end region of the tissue penetrator from within thelower jaw to deflect laterally out of the lower jaw through the targettissue and through the upper jaw comprises pushing the distal end regionof the tissue penetrator against a clamping mechanism in the upper jawas the distal end region of the tissue penetrator is extended throughthe upper jaw.
 19. The method of claim 10, further comprising removingthe suture passer from the target tissue and releasing the loop ofsuture from the suture passer as the suture passer is removed from thetarget tissue.